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U.S. Department of Health and Human Services

Class 2 Device Recall Catalyst System

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 Class 2 Device Recall Catalyst Systemsee related information
Date Initiated by FirmAugust 06, 2020
Create DateJuly 14, 2021
Recall Status1 Terminated 3 on April 15, 2022
Recall NumberZ-2075-2021
Recall Event ID 88084
510(K)NumberK113276 
Product Classification Accelerator, linear, medical - Product Code IYE
ProductPC Application Software c4D as part of the device Catalyst: SP-002 Software PA-003 version 6.1.1 and 6.1.0
Code Information Catalyst: SP-002, Software (part number): PA-003 version 6.1.1 and 6.1.0
Recalling Firm/
Manufacturer		 C-RAD POSITIONING AB
Bredgrand 18
Uppsala Sweden
For Additional Information ContactTim Thurn
4618666930
Manufacturer Reason
for Recall		PC Application Software c4D not changing Site upon synchronization during the Setup workflow step
FDA Determined
Cause 2		Component change control
ActionOn August 11, 2020, an e-mail letter containing PA-003-200806-001-01, c4D not changing Site upon synchronization during the Setup workflow step (attached) has been sent personally to our contact persons at the affected sites. In a second step C-RAD upgraded the software at all affected sites to bring back the system to the originally intended state..
Quantity in Commerce7
DistributionUS Nationwide distribution in the states of IL, KY, MO and WA.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = IYE
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